Exam 2 : Lecture Interventional Flashcards
(45 cards)
Other terms for interventional
Clinical trial Clinical study Experimental study Human study Investigational study
Interventional studies are MORE rigorous in ability to show cause-and-effect . T or F
True
Interventional studies CANT demonstrate causation. T or F?
False. They CAN
Prior to human investigation this level used animal research “bench”
Pre-clinical
In this phase we:
- Assess drug target actions and pharmacokinetics in non therapeutic/non-diagnostic doses
- Healthy volunteers (diseased in oncology)
- Very small numbers
- Very short duration
Phase 0
In this phase we:
1. Assess safety/tolerance and pharmacokinetics of one or more dosages
2. Healthy or disease volunteers (depends on disease)
3. Small numbers (20-80)
Short duration (just a few weeks)
Phase 1
In this phase we:
- Asses effectiveness
- Disease volunteers
- Larger number (100-300)
- Short to medium duration (few weeks to a few months)
Phase 2
In this phase we:
- Asses effectiveness
- Diseased volunteers
- superiority
- noninferiority
- equivalency - Larger number (300-500)
- Longer duration (few months to a year +)
Phase 3
Phase three can be run multiple times, T or F?
True. It can be run multiple times
If the drug isn’t yet on the market, what phase is it in?
Phase 3
Every time phase three is tested, it must be successful to move on to stage 4. T or F?
False. It just needs to majoritively test positive
In this phase we:
- Assess long-term safety, effectiveness, optimal use
- Diseased voulnteers
- Population (100,000)
- Longer duration (many years to decades)
Phase 4
FDA approval phase
Phase 4
What are some advantages of interventional trials
- Cause precedes effect (can demonstrate causation)
2. Only design-family used by FDA for “approval” process
Disadvantages of interventional trials?
Cost
Complexity
Ethical considerations
Generalizability
This interventional study divides subjects exclusively int o2 or more groups. Asks a single question. What study design is it?
Simple
This interventional study design divides subjecting into 2 or more groups and then further sub divides each of the groups into 2 more additional groups. Tests multiple hypothesis. What design is this?
Factorial
What are some benifits and risks to using factorial interventional studies?
Improves efficiency for answering clinical questions Increases study population sample size Increases complexity Increases risk of drop outs May restrict generalizability of results
Are simple and factorial study designs also parallel?
Yes
NO SWITCHING
In this interventional study design groups serve as their own control by crossing over from one intervention to another during the study. What design is this?
Cross-over (self control)
Which interventional design has a wash out phase?
Cross-over
Disadvantages of cross-over design?
- Only suitable for long-term conditions which are not curable or which treatment provides short-term relief
- Duration of study for each subject is longer
- Carry-over effects during cross-over
- Treatment by period interaction
- Smaller number requirement only applicable if within subjects variation less than between subjects variation
- Complexity in data analysis
Patient oriented endpoint (POEM’s)
Death
Stroke
Hospitalization
Preventing need for dialysis
Disease oriented endpoints (DOE’s)
Blood pressure
Cholesterol
Change in SCr
